CompletedPhase 3

DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

United States608 participantsStarted 2018-08-01

Plain-language summary

This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: * cannot be removed by an operation * has spread to other parts of the body

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. is unresectable or metastatic
✓. has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
✓. was previously treated with ado-trastuzumab emtansine (T-DM1)
✓. 7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males)
✓. 6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants)
✓. 7 months after the last dose of trastuzumab/capecitabine

What they're measuring

Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine

Timeframe: Baseline up to 46 months postdose

Trial details

NCT IDNCT03523585

SponsorDaiichi Sankyo

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-30

Results submitted2023-05-30

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